Regulatory
Compliance
We operate within India's healthcare regulatory framework and uphold the highest standards of data and medical compliance.
Regulatory Bodies We Comply With
NBTC
National Blood Transfusion Council
All blood management operations follow NBTC guidelines on collection, testing, storage, and distribution.
FDCA Maharashtra
Food & Drug Control Administration
Our blood bank partner operations are licensed and inspected by FDCA Maharashtra.
ABDM
Ayushman Bharat Digital Mission
We are aligned with ABDM's health data standards and are working towards full interoperability.
DPDPA 2023
Digital Personal Data Protection Act
All personal data handling complies with India's DPDPA 2023 framework.
Our Commitments
- Blood products are tracked from collection to transfusion with full traceability
- Donor consent is obtained digitally and stored securely for regulatory audits
- All partner blood banks hold valid FDCA licenses and NBTC accreditation
- Emergency request data is retained for minimum 5 years for compliance reporting
- We submit quarterly MIS reports to NBTC on blood unit distribution and wastage
Contact Compliance Team
For compliance-related inquiries, contact us at compliance@omnexahealthtech.com